deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT04505826

A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects With Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer

Sponsor: Olema Pharmaceuticals, Inc.

Interventions OP-1250
Updated 10 times since 2020 Last updated: Jul 30, 2025 Started: Aug 13, 2020 Primary completion: Jul 30, 2024 Completion: Jul 30, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates HER2-negative Breast Cancer and Hormone Receptor Positive Breast Carcinoma and is currently completed. Olema Pharmaceuticals, Inc. leads this study, which shows 10 recorded versions since 2020 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshotRecruiting~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshotRecruiting~Jun 2021 – ~Nov 2021 · 5 months · monthly snapshotRecruiting~Nov 2021 – ~May 2023 · 18 months · monthly snapshotRecruiting~May 2023 – ~Jun 2023 · 31 days · monthly snapshotRecruiting~Jun 2023 – ~Sep 2023 · 3 months · monthly snapshotRecruiting~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotActive Not Recruiting~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotActive Not Recruiting~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE1/PHASE2

    Status: Active Not RecruitingCompleted

  2. Sep 2024 — Sep 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. Sep 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: RecruitingActive Not Recruiting

  5. Jun 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

Show 5 earlier versions
  1. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE1_PHASE2

  2. Nov 2021 — May 2023 [monthly]

    Recruiting PHASE1_PHASE2

  3. Jun 2021 — Nov 2021 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jan 2021 — Jun 2021 [monthly]

    Recruiting PHASE1_PHASE2

  5. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Aug 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Olema Pharmaceuticals, Inc.
Data source: Olema Pharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .